An Unconventional Approach to Focusing Clinical Trials Posted December 3, 2015The scientific challenges in identifying promising new compounds and bringing them to market may be the most difficult part of new drug development. But the costs and challenges associated with clinical trials is increasingly viewed as another significant barrier, according to a new study from the U.S. Department of Health and Human Services. The major obstacles to conducting clinical trials in the United States identified through this research include: high financial cost, the lengthy time frames, difficulties in recruitment and retention of participants, insufficiencies in the clinical research workforce, … the disconnect between clinical research and medical care… Given that Phase 1, 2 and 3 trials can cost $40-$70 million, improvements can pay real dividends. But the authors recognize the upside outside of simple cost saving: Improving the drug development process, especially by conducting better (meaning providing more information on safety or efficacy) and faster clinical trials, can foster innovation in medical product development. We believe data mining and signal detection have an important role to play in focusing clinical trials. These capabilities can be an effective complement to “gold-standard” of double-blind, case-control studies. But creativity in finding the right participants can also help. Consider a unique clinical trial underway with the U.S. Army and the makers of a new drug designed to treat hearing loss. The trial is testing an experimental drug that might prevent noise-induced hearing loss … a persistent problem for soldiers repeatedly firing loud weapons. Yes, the product is innovative; no drugs designed to treat hearing loss are currently on the market. The article continues: Clinical trials of drug candidates are normally the province of pharmaceutical or biotechnology companies, and she did work with a small biotech at one point. But the arrangement collapsed, leaving Dr. Campbell without a partner. She continued pursuing development on her own, but it wasn’t easy to find a large test population of people who are repeatedly exposed to loud noises. It’s important to note that even the largest pharmaceuticals can be challenged to find the right populations, too. That’s one driving factor behind the high cost of clinical trials. The ideal is to focus researchers on the most likely and most important demographic and epidemiological risks. And, getting back to product innovation, signals about positive side effects mean that potential new indications can be incorporated in the design of large-scale studies.